FDA applicant
Oricare, Inc.
FDA records 4 decisions for Oricare, Inc. (Quakertow., PA) from 2012 to 2014: 4 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTI (Compressor, Air, Portable). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oricare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Oricare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report